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New treatment option for Long Covid
Official title Antiviral Clinical Trial for Long Covid-19
ClinicalTrials.gov ID: NCT06511063
What this study is testing
What is tenofovir disoproxil/emtricitabine?
tenofovir disoproxil/emtricitabine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for long covid.
Also referred to as TDF/FTC, Truvada.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The trial will test if two repurposed HIV antivirals can reduce symptom burden in adult participants with Long Covid compared to placebo. Viral infection and viral reactivation have been documented in Long Covid.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Any gender, aged 18+
- Diagnosed with:
- Long Covid
You likely can't join if
- Pre-existing conditions including, but not limited to:
- Autoimmune conditions such as Chronic EBV, Multiple Sclerosis, Hashimoto's Disease, etc. which would impact the immunological profiling analysis.
- A pre-2020 diagnosis of another Post-Acute Infectious Syndrome such as Chronic Lyme disease, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, etc.
- Documented history of vaccine injury
- Or any other chronic condition that has the potential to impact on immunological profiling, at the discretion of the research physician
- HIV+ status
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Any gender, aged 18+
- Diagnosed with:
- Long Covid
- Documented clinical history of confirmed or suspected acute SARS-CoV-2 infection a minimum of 6 months prior to contact with the study team
- Formal diagnosis of Long Covid from a physician and a history of 6 months of Long COVID symptoms
- At least a six-month history of one of the following symptoms following SARS-CoV-2 infection:
- headache, memory loss, insomnia, mood disturbance, chest pain, palpitations, shortness of breath, cough, muscle pains, joint pains, or GI upset] AND at least moderate fatigue (measured by Fatigue Severity Score) AND at...
- Participants who are willing and able to comply with all data collection, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Baseline EQ-VAS ≤70; EQ-VAS before the index infection ≥80 (this information is collected before randomization as part of the baseline survey).
- Pre-existing conditions including, but not limited to:
- Autoimmune conditions such as Chronic EBV, Multiple Sclerosis, Hashimoto's Disease, etc. which would impact the immunological profiling analysis.
- A pre-2020 diagnosis of another Post-Acute Infectious Syndrome such as Chronic Lyme disease, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, etc.
- Documented history of vaccine injury
- Or any other chronic condition that has the potential to impact on immunological profiling, at the discretion of the research physician
- HIV+ status
- Current use of either Truvada or Selzentry
- Taking a medication, within 6 weeks, with known interactions with Truvada or Selzentry including but not limited to: Acyclovir, valacyclovir, adefovir, cabozantinib, carbamazepine, cidofovir, cladribine, cobicistat...
- Current treatment with drugs known to affect EBV replication, including but not limited to: Acyclovir, valacyclovir, ganciclovir, valganciclovir, famciclovir, teriflunomide, interferon
- Known allergic reactions to components of Truvada or Selzentry
- Febrile illness within the last 3 months of planned baseline evaluation
- Treatment with another investigational drug or other investigational intervention within 6 months of planned baseline evaluation
- Immunosuppressed individuals (transplant on antiviral prophylaxis and/or patients taking immunosuppressive medications such as steroids, etc.)
- Known medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic or active hepatitis B or C infection, primary biliary cirrhosis, Child-Pugh Class B or C, or acute liver...
- Receiving dialysis or have known renal impairment
- Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within days prior to study entry, as determined by the study team
- Other medical or psychiatric conditions, in the treating investigator's judgment, that makes the participant inappropriate for the study
- Unknown HIV status (people must have completed HIV antigen/antibody and viral load testing completed at the screening visit)
- Active or latent hepatitis B (people must have completed HBV serologies - HbsAg, anti-HBs, and anti-HBc - testing completed at the screening visit)
- Current symptoms of severe, progressive, or uncontrolled renal, hematologic, gastrointestinal, pulmonary, cardiac, or neurologic disease, or other medical conditions that, in the opinion of the investigator, might place...
- Creatinine clearance (CrCl) \<75mL/min, as calculated by the Cockcroft-Gault equation
- Any history of bone fractures not explained by trauma
- Confirmed Grade 2 or greater hypophosphatemia
- Any Grade 2 or greater toxicity on screening tests and assessments
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.